Comparison of nephrotoxic effects of the contrast dyes iodixanol (iso-osmolar, non-ionic, dimer) and ioversol (low-osmolar, non-ionic, monomer) in patients with impaired renal function and severe heart failure

niversity Hospital of Frankfurt, Department of Cardiology0 个研究点目标入组 140 人开始时间: 2005年5月17日最近更新: 2021年10月8日

试验速览

暂无简介。

•- Patients must be older than 18 y.o.
•- Written consent to the study
•- Coronary angiography is required for medical reasons
•- Calculated glomerular filtration rate = 60 ml/min (calculation is based on the shortened MDRD-formula)
•- Severe heart failure, diagnosed either by an ejection fraction = 45 % (echocardiography) or a clinical condition NYHA III or IV
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Severe comorbidity (i.e. neoplasia, life expectaning = 2 yrs.)
•- Intravacular administration of iodinated contrast dye within last 14 days
•- Intake of nephrotoxic drugs within the last 7 days
•- Intake of metformine within the last 24 hours
•- Patients with prior renal transplantation
•- End-stage renal disease or acute renal failure and/or necessity of dialysis after coronary angiography
•- Pregnancy or lactation
•- Impaired liver function following the Child-Pugh criteria according a severity level of Child B or C

发起方

niversity Hospital of Frankfurt, Department of Cardiology